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Bile Acid Sequestrant

Linerixibat for Cholestasis (LLSAT Trial)

Phase 3

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN.

Be older than 18 years old

Must not have

Any current malignancies (including hematologic and solid malignancies).

Current diagnosis or previous diagnosis of colorectal cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 66 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing the safety and tolerability of the drug linerixibat in people with a condition called cholestatic pruritus, who have participated in other clinical trials for the same drug. All participants will receive linerixibat during the study, which is expected to last until the drug can be made available for general use. The total duration of the study will vary depending on when each participant joins and the availability of the drug in their country.

Who is the study for?

This trial is for adults aged 18-80 with primary biliary cholangitis (PBC) and itching, who've been in a prior linerixibat study. They must not be pregnant or breastfeeding, have significant liver function issues, certain cancers, severe kidney problems, or use conflicting medications.

What is being tested?

The trial tests the long-term safety of linerixibat in patients with PBC-related itching. It's an open-label study where all participants receive the drug. The duration varies until linerixibat becomes legally available to them.

What are the potential side effects?

Potential side effects of linerixibat may include gastrointestinal symptoms like diarrhea. Since it's focused on long-term safety, monitoring will capture any new or ongoing side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old and have consented to participate in a trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no other cancers besides the one being treated.

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I have been diagnosed with colorectal cancer.

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I have severe liver issues like bleeding, confusion, or fluid in the abdomen.

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I have an active hepatitis B or C infection, liver disease, or liver/biliary cancer.

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I have not taken any IBAT inhibitors in the last month.

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I am currently experiencing symptoms of gallstones or gallbladder inflammation.

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I haven't taken Obeticholic acid in the last 8 weeks.

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I drink more than the moderate daily alcohol limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 66 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 66 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 66 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with Severe AEs

Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)

Secondary study objectives

Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)

Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)

Change in domain scores of the PBC-40 over time

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants receiving linerixibatExperimental Treatment1 Intervention

Participants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER \[Group 1\]) and Phase 3 study (212620 GLISTEN \[Group 2\]), will receive linerixibat.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Linerixibat

2022

Completed Phase 1

~60

0 / 9Eligibility criteria met